Prescription drug · ANDA
Diphenoxylate Hydrochloride and Atropine Sulfate NDC 0406-1236
Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 · Tablet · Oral · SpecGx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0406-1236-01 | 0040612360100406123601 | 100 TABLET in 1 BOTTLE (0406-1236-01)Marketed from Oct 30, 2020 | |
| 0406-1236-10 | 0040612361000406123610 | 1000 TABLET in 1 BOTTLE (0406-1236-10)Marketed from Oct 30, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Diphenoxylate Hydrochloride and Atropine Sulfate
- Generic name (nonproprietary)
- diphenoxylate hydrochloride and atropine sulfate
- Active ingredients
- Diphenoxylate hydrochloride — 2.5 mg/1Atropine sulfate — .025 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- SpecGx LLCNDC labeler code 0406
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213335
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 0406-1236_c7a8d21f-365e-4a00-a7bf-4ee5fc6c2406SPL ID c7a8d21f-365e-4a00-a7bf-4ee5fc6c2406SPL set ID 24915aa0-1600-44bb-99fc-46529a794124RxCUI 1190572UNII W24OD7YW48, 03J5ZE7KA5UPC 0304061236102
- Pharmacologic class
- Anticholinergic; Antidiarrheal; Cholinergic Muscarinic Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400406123601followed by a unit qualifier and the quantityPackage 00406-1236-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Diphenoxylate hydrochloride and atropine sulfate tablets are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.
Excerpt only. Read the full label for complete information.
About NDC 0406-1236
- What is NDC 0406-1236?
- 0406-1236 is the product NDC for Diphenoxylate Hydrochloride and Atropine Sulfate, Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 tablet, listed with the FDA by SpecGx LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diphenoxylate Hydrochloride and Atropine Sulfate.
- What is the active ingredient?
- Diphenoxylate hydrochloride, Atropine sulfate.
- Who is the labeler?
- SpecGx LLC, NDC labeler code 0406. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diphenoxylate Hydrochloride and Atropine Sulfate?
- 26 other product NDCs are listed under this name. See all Diphenoxylate Hydrochloride and Atropine Sulfate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diphenoxylate Hydrochloride and Atropine Sulfate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | American Health Packaging | 60687-890 | 60687-0890-01 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3915 | 70518-3915-01 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | Winder Laboratories LLC | 75826-107 | 75826-0107-0075826-0107-0375826-0107-11+2 more |
| Diphenoxylate Hydrochloride And Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | Direct Rx | 72189-336 | 72189-0336-1072189-0336-30 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8090 | 68788-8090-02 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-714 | 71610-0714-3071610-0714-5371610-0714-60+3 more |
| Diphenoxylate hydrochloride and atropine sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | Chartwell RX, LLC | 62135-618 | 62135-0618-12 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | Redpharm Drug | 67296-2240 | 67296-2240-05 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | Redpharm Drug Inc. | 67296-1485 | 67296-1485-09 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-375 | 72789-0375-25 |
All 27 Diphenoxylate Hydrochloride and Atropine Sulfate NDCs
Other NDCs under ANDA 213335
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | American Health Packaging | 60687-890 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-714 |